Woo More Play Coconut Love Oil is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Description

Woo More Play Coconut Love Oil is a non-sterile, flavored, oil-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. Its formulation consists of Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Beeswax, Deionized Water, Stevia Rebaudiana Leaf Extract, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, and Natural Flavor. Woo More Play Coconut Love Oil is for over-the-counter (OTC) use and is packaged in 3.3 oz. non-sterile bottles.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant, "Woo More Play Coconut Love Oil." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on bench testing of physical and chemical properties and biocompatibility, not on clinical performance or AI/software-based evaluations.

Therefore, many of the requested details, such as those pertaining to AI/algorithm performance, MRMC studies, human reader improvement, multi-expert ground truth establishment, and training/test set sample sizes for AI models, are not applicable to this type of medical device submission.

As such, I will answer the questions that are relevant to the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a "Device Specifications" table (Table 1) which serves as the acceptance criteria for various parameters of the Woo More Play Coconut Love Oil. The "reported device performance" is implicitly stated by confirming that the device met these specifications, specifically noted under the "Shelf Life" section.

Parameter	Test Method	Acceptance / Specification	Reported Device Performance
Appearance	Visual	Opaque; thin liquid to semi-solid	Met specification at all time points (over 3-month shelf-life)
Color	Visual	White to off-white	Met specification at all time points (over 3-month shelf-life)
Odor	Olfactory	Characteristic	Met specification at all time points (over 3-month shelf-life)
pH	USP <791>	4.0-5.5	Met specification at all time points (over 3-month shelf-life)
Viscosity	USP <912>	500-2,000 cPs	Met specification at all time points (over 3-month shelf-life)
Osmolality	N/A	N/A	Not applicable/Not tested for this criterion
Water Activity	USP <1112>	<0.7aw	Met specification at all time points (over 3-month shelf-life)
Antimicrobial Effectiveness	USP <51>	Meets USP <51> acceptance criteria for Category 2 products. Category 2, bacteria should show not less than 2.0 log reduction at 14 days and no increase from the 14-day count to the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days	Met specification at all time points (over 3-month shelf-life)
Total Microbial Count	USP <61> and <1111>	<100 cfu/g	Met specification at all time points (over 3-month shelf-life)
Fungal/Yeast/Mold Limits	USP <61> and <1111>	<10 cfu/g	Met specification at all time points (over 3-month shelf-life)
Absence of Pathogenic Organisms (Staphylococcus Aureus, Pseudomonas Aeruginosa, Candida Albicans)	USP <62>	Absent	Met specification at all time points (over 3-month shelf-life)
Specific gravity	USP <841>	0.86-0.96	Met specification at all time points (over 3-month shelf-life)

2. Sample sized used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/ML model for performance evaluation. Instead, it refers to non-clinical performance testing for various physical, chemical, and biological properties.

Sample Size: The document does not explicitly state the number of samples or batches used for each specific test (e.g., pH, viscosity, microbial limits). It implies that testing was conducted on samples to demonstrate adherence to specifications and across the 3-month shelf-life.
Data Provenance: The data provenance is internal testing performed by the manufacturer (Woo Essentials, Inc.) to support their 510(k) submission. This is not retrospective or prospective in the sense of clinical study data collection from particular countries/populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. "Ground truth" established by experts in the context of medical image analysis or similar AI applications is not relevant here. The "ground truth" for this device's performance is determined by established laboratory test methods (e.g., USP standards) and the resulting measurements against predefined specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations, which is not relevant to laboratory testing of physical and chemical properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a personal lubricant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a personal lubricant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on objective measurements obtained through validated laboratory test methods (e.g., USP standards) against predefined acceptance criteria (specifications). For biological compatibility, the ground truth is established through standardized biocompatibility assays (e.g., Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) according to ISO standards, demonstrating non-toxic, non-irritating, and non-sensitizing properties.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

This question is not applicable. There is no "training set" for which ground truth would be established.

Summary

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December 1, 2023

Woo Essentials, Inc. Mackie Swan CEO 1801 Brackenridge St. A Austin, TX 78704

K232093 Re: Trade/Device Name: Woo More Play Coconut Love Oil Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 1, 2023 Received: November 1, 2023

Dear Mackie Swan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232093

Device Name Woo More Play Coconut Love Oil

Indications for Use (Describe)

Woo More Play Coconut Love Oil is a personal lubricant for vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary — K232093 Woo More Play Coconut Love Oil

l. General Information on Submitter

Applicant:	Woo Essentials, Inc.
Address:	1801 Brackenridge St. AAustin, TX78704
Telephone:	858-634-0994
Contact Person:	Mackie Swan
Contact Title:	CEOWoo Essentials, Inc.
Email:	mackie@woomoreplay.com
Date Prepared:	November 29, 2023

II. General Information on Device

Proprietary Name:	Woo More Play Coconut Love Oil
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR 884.5300
Regulatory Class:	II
Product Code:	NUC (Lubricant, Personal)

lll. Predicate Device

Predicate Device	510(k) Number
Bloomi Delight Oil-Based Personal Lubricant	K222175

This predicate device has not been subject to a design-related recall.

IV. Description of Device

Woo More Play Coconut Love Oil is for over-the-counter (OTC) use and is packaged in 3.3 oz. non-sterile bottles.

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The specifications for the Woo More Play Coconut Love Oil are described in Table 1.

Parameter	Test Method	Specification
Appearance	Visual	Opaque; thin liquid to semi-solid
Color	Visual	White to off-white
Odor	Olfactory	Characteristic
pH	USP <791>	4.0-5.5
Viscosity	USP <912>	500-2,000 cPs
Osmolality	N/A	N/A
Water Activity	USP <1112>	<0.7aw
AntimicrobialEffectiveness	USP <51>	Meets USP <51> acceptancecriteria for Category 2products. Category 2,bacteria should show not lessthan 2.0 log reduction at 14days and no increase fromthe 14-day count to the 28-day count. Yeast and moldsshould show no increasefrom the initial calculatedcount at 14 and 28 days
Total Microbial Count	USP <61> and<1111>	<100 cfu/g
Fungal/Yeast/MoldLimits	USP <61> and<1111>	<10 cfu/g
Absence of PathogenicOrganisms(StaphylococcusAureus, PseudomonasAeruginosa, CandidaAlbicans)	USP <62>	Absent
Specific gravity	USP <841>	0.86-0.96

Table 1. Device Specifications

V. Indications for Use

VI. Substantial Equivalence Discussion

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A comparison of the intended use and technological features of the subject and predicate devices is provided in Table 2 below:

Table 2. Intended Use and Technological Characteristics of Subject Device Compared to Predicate Device

Characteristic /Feature	Woo More Play CoconutLove Oil (subject device)	Bloomi Delight Oil-Based PersonalLubricant (predicatedevice) - K222175	Comparison
Indication for use	Woo More Play Coconut LoveOil is a personal lubricant forpenile and/or vaginalapplication, intended tolubricate, moisturize, andenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product is notcompatible with natural rubberlatex, polyurethane, andpolyisoprene condoms.	The Bloomi Delight Oil-BasedPersonal Lubricant is apersonal lubricant for penileand/or vaginal application,intended to lubricate,moisturize, and enhance theease and comfort of intimatesexual activity and supplementthe body's natural lubrication.This product is not compatiblewith natural rubber latex,polyurethane, andpolyisoprene condoms.	Same
Appearance	Opaque, thin liquid to semi-solid	Semi-fluid	Different
Color	White to Off-White	Yellow	Different
Odor	Characteristic	Odorless	Different
Viscosity	500-2,000 cPs	2,300-20,000 cPs	Different
Over the Counter	Yes	Yes	Same
Water Activity	<0.7aw	Not available	Different
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	Cocos Nucifera (Coconut) Oil,Caprylic/Capric Triglyceride,Beeswax, Deionized Water,Stevia Rebaudiana LeafExtract, Jojoba Esters,Helianthus Annuus (Sunflower)Seed Wax, Acacia DecurrensFlower Wax, Polyglycerin-3,and Natural Flavor	Extra Virgin Coconut Oil,Organic Sunflower Seed Oil,Organic Cocoa Butter, SheaButter, Sunflower Wax, andSea Buckthorn Fruit Oil	Different: The ingredients of thepredicate device are different;the ingredients do not raisedifferent questions of Safety &Effectiveness (S & E)
Microbial Limits	Total mold/yeast count <10 cfu/mLTotal aerobic microbial count <100 cfu/mLAbsence of pathogens (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus)	Total mold/yeast count <100 cfu/mLTotal aerobic microbial count <10 cfu/mLAbsence of pathogens (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus)	Same
CondomCompatibility	Not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms	Not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms	Same

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The subject and predicate devices have identical indications for use statements and have the same intended use - to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.

VII. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009/(R)2014) ●
Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
Vaginal Irritation (ISO 10993-23: 2021) ●
Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.

Shelf Life

The subject device is a non-sterile personal lubricant packaged in 3.3 oz. non-sterile bottles with a 3-month shelf-life in accordance with the results of a real-time aging study. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.

Condom Compatibility

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Condom compatibility testing was not conducted for the subject device. Therefore, Woo More Play Coconut Love Oil is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

VIII. Conclusion

The results of the testing described above demonstrate that Woo More Play Coconut Love Oil is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.